A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | February 2014 |
| End Date: | March 2014 |
A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects
This Phase I, open-label, randomized, 2-period crossover study was designed to determine the
relative bioavailability of ipatasertib administered as capsule and tablet formulations to
healthy adult volunteers. Participants will be randomized to one of two treatment sequences
to receive a single oral administration of ipatasertib in tablet or capsule formulation
followed, after a washout period, by a single oral administration of ipatasertib in the
second formulation. Pharmacokinetics will be assessed, and standard physical and clinical
evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
relative bioavailability of ipatasertib administered as capsule and tablet formulations to
healthy adult volunteers. Participants will be randomized to one of two treatment sequences
to receive a single oral administration of ipatasertib in tablet or capsule formulation
followed, after a washout period, by a single oral administration of ipatasertib in the
second formulation. Pharmacokinetics will be assessed, and standard physical and clinical
evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
Inclusion Criteria:
- Healthy male and female volunteers aged 18 to 55 years, inclusive
- Body mass index (BMI) from 18.5-29.9 kg/m2, inclusive
Exclusion Criteria:
- Clinically significant findings from medical history or screening evaluations
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